PK Study of Telmisartan/Rosuvastatin FDC Compared to Combination of Telmisartan and Rosuvastatin
Information source: Yuhan Corporation
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Dyslipidemia & Hypertension
Intervention: Crestor 20mg(Rosuvastatin 20mg), Micardis 80mg(Telmisartan 80mg) , FDC (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Yuhan Corporation
Summary
This is a 2 by 2 cross-over study to evaluate pharmacokinetics of telmisartan and
rosuvastatin FDC compared to reference telmisartan and rosuvastatin coadministered in two
groups enrolling healthy adult male and female subjects under fasting conditions.
Subjects will be admitted to the clinic in the evening before Day 1. All subjects will
receive a single oral dose of telmisartan/rosuvastatin FDC or telmisartan and rosuvastatin
co-administered in the morning on Day 1. All the subjects will remain in the clinical unit
until completion of all assessments on Day 2 including collection post-dose PK sample.
Subjects will return to the clinic for pharmacokinetic samples at scheduled time.
The two treatment periods will be separated by a washout period.
Clinical Details
Official title: A Randomized, Open-label, Single-dose, 2-way Cross-over Study to Compare the Safety and the Pharmacokinetic Characteristics of the Co-administration of Telmisartan and Rosuvastatin and YH16410 in Healthy Volunteers
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label
Primary outcome: plasma pharmacokinetic parameters for telmisartan and rosuvastatin in relevant treatments
Eligibility
Minimum age: 20 Years.
Maximum age: 50 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Healthy male and female aged 20 to 50 with a body mass index(BMI) between 18. 5 and 25
kg/m2
2. Acceptable medical history, physical examination, laboratory tests and EKG, during
screening
3. Provision of signed written informed consent 20~50 yrs old, healthy Korean Subjects
Exclusion Criteria:
1. History of and clinically significant disease
2. Sitting blood pressure meeting the following criteria at screening: 150 ≥ systolic
blood pressure ≤100 (mmHg) and 100 ≥ diastolic blood pressure ≤ 65 (mmHg) amd 100 ≥
Heart rate ≤ 40
3. A history of drug abuse or the presence of positive reactions to drugs that have
abuse potential in urine screenings for drugs.
4. Administration of other investigational products within 90 days prior to the first
dosing.
5. Administration of herbal medicine within 28 days or administration of ethical drugs
within 14 days or administration of over-the-counter (OTC) drugs within 7 days prior
to the first dosing of the investigational product (if the investigator (study
doctor) determines that the person meets other criteria appropriately, the relevant
person may participate in the study).
6. Have AST(SGOT) or/and ALT(SGPT) > 3 times of normal upper limit at the time of
screening
7. Volunteers considered not eligible for the clinical trial by the investigator (study
doctor) due to reasons including laboratory test results, ECGs, or vital signs.
Locations and Contacts
Severance Hospital, Seoul, Korea, Republic of
Additional Information
Starting date: July 2013
Last updated: October 28, 2013
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